Desirability of outcome ranking for obstetrical trials: illustration and application to the ARRIVE trial.

BACKGROUND: In randomized trials, 1 primary outcome is typically chosen to evaluate the consequences of an intervention, whereas other important outcomes are relegated to secondary outcomes. This issue is amplified for many obstetrical trials in which an intervention may have consequences for both the pregnant person and the child. In contrast, desirability of outcome ranking, a paradigm shift for the design and analysis of clinical trials based on patient-centric evaluation, allows multiple outcomes-including from >1 individual-to be considered concurrently. OBJECTIVE: This study aimed to describe desirability of outcome ranking methodology tailored to obstetrical trials and to apply the methodology to maternal-perinatal paired (dyadic) outcomes in which both individuals may be affected by an intervention but may experience discordant outcomes (eg, an obstetrical intervention may improve perinatal but worsen maternal outcomes). STUDY DESIGN: This secondary analysis applies the desirability of outcome ranking methodology to data from the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network ARRIVE trial. The original analysis found no substantial difference in the primary (perinatal composite) outcome, but a decreased risk of the secondary outcome of cesarean delivery with elective induction at 39 weeks. In the present desirability-of-outcome-ranking analysis, dyadic outcomes ranging from spontaneous vaginal delivery without severe neonatal complication (most desirable) to cesarean delivery with perinatal death (least desirable) were classified into 8 categories ranked by overall desirability by experienced investigators. Distributions of the desirability of outcome ranking were compared by estimating the probability of having a more desirable dyadic outcome with elective induction at 39 weeks of gestation than with expectant management. To account for various perspectives on these outcomes, a complementary analysis, called the partial credit strategy, was used to grade outcomes on a 100-point scale and estimate the difference in overall treatment scores between groups using a t test. RESULTS: All 6096 participants from the trial were included. The probability of a better dyadic outcome for a randomly selected patient who was randomized to elective induction was 53% (95% confidence interval, 51-54), implying that elective induction led to a better overall outcome for the dyad when taking multiple outcomes into account concurrently. Furthermore, the desirability-of-outcome-ranking probability of averting cesarean delivery with elective induction was 52% (95% confidence interval, 51-53), which was not at the expense of an operative vaginal delivery or a poorer outcome for the perinate (ie, survival with a severe neonatal complication or perinatal death). Randomization to elective induction was also advantageous in most of the partial credit score scenarios. CONCLUSION: Desirability-of-outcome-ranking methodology is a useful tool for obstetrical trials because it provides a concurrent view of the effect of an intervention on multiple dyadic outcomes, potentially allowing for better translation of data for decision-making and person-centered care.

Neurodevelopmental Outcomes After Late Preterm Antenatal Corticosteroids: The ALPS Follow-Up Study.

Importance: The Antenatal Late Preterm Steroids (ALPS) trial changed clinical practice in the United States by finding that antenatal betamethasone at 34 to 36 weeks decreased short-term neonatal respiratory morbidity. However, the trial also found increased risk of neonatal hypoglycemia after betamethasone. This follow-up study focused on long-term neurodevelopmental outcomes after late preterm steroids. Objective: To evaluate whether administration of late preterm (34-36 completed weeks) corticosteroids affected childhood neurodevelopmental outcomes. Design, Setting, and Participants: Prospective follow-up study of children aged 6 years or older whose birthing parent had enrolled in the multicenter randomized clinical trial, conducted at 13 centers that participated in the Maternal-Fetal Medicine Units (MFMU) Network cycle from 2011-2016. Follow-up was from 2017-2022. Exposure: Twelve milligrams of intramuscular betamethasone administered twice 24 hours apart. Main Outcome and Measures: The primary outcome of this follow-up study was a General Conceptual Ability score less than 85 (-1 SD) on the Differential Ability Scales, 2nd Edition (DAS-II). Secondary outcomes included the Gross Motor Function Classification System level and Social Responsiveness Scale and Child Behavior Checklist scores. Multivariable analyses adjusted for prespecified variables known to be associated with the primary outcome. Sensitivity analyses used inverse probability weighting and also modeled the outcome for those lost to follow-up. Results: Of 2831 children, 1026 enrolled and 949 (479 betamethasone, 470 placebo) completed the DAS-II at a median age of 7 years (IQR, 6.6-7.6 years). Maternal, neonatal, and childhood characteristics were similar between groups except that neonatal hypoglycemia was more common in the betamethasone group. There were no differences in the primary outcome, a general conceptual ability score less than 85, which occurred in 82 (17.1%) of the betamethasone vs 87 (18.5%) of the placebo group (adjusted relative risk, 0.94; 95% CI, 0.73-1.22). No differences in secondary outcomes were observed. Sensitivity analyses using inverse probability weighting or assigning outcomes to children lost to follow-up also found no differences between groups. Conclusion and Relevance: In this follow-up study of a randomized clinical trial, administration of antenatal corticosteroids to persons at risk of late preterm delivery, originally shown to improve short-term neonatal respiratory outcomes but with an increased rate of hypoglycemia, was not associated with adverse childhood neurodevelopmental outcomes at age 6 years or older.

Body composition in term neonates of mothers with hypertensive disorders of pregnancy.

BACKGROUND: Neonates of gravidas with hypertensive disorders of pregnancy (HDP) are at increased lifelong risk of cardiometabolic complications. Neonatal adiposity measured by body composition (BC) is a better surrogate of nutritional status than birth weight. Data comparing BC in term neonates of hypertensive and normotensive pregnant patients is lacking. Our objective was to compare body composition in both groups of neonates. METHODS: This was a retrospective cohort study from March 2018 to June 2019 at our tertiary institution where term neonatal BC are routinely measured. Neonates of patients with HDP and matched controls were included. Skin fold thickness (SFT) and percent body fat (PBF) were calculated using a validated anthropometric formula and compared using Mann-Whitney U and chi-square tests. RESULTS: One hundred and forty-two neonates of patients with HDP were compared to 150 controls. Demographic characteristics were similar except for higher pre-pregnancy BMI (29.7 ± 8.4 vs 26.75 ± 7.1, p = <0.01) in the HDP group. SFT was not significantly different (4.6 vs 4.4 mm, p = 0.09) but PBF was higher in the hypertensive group (13.15 vs 11.72, p = 0.01). CONCLUSIONS: PBF is higher in neonates of mothers with HDP, which may contribute to an increased risk of cardiometabolic complications later in life. IMPACT: Birth weight percentiles do not explain the predisposition to cardiovascular complications in offspring of hypertensive mothers. Body composition estimation may provide an explanation for this increased risk. Percent body fat is higher in term neonates of mothers with hypertensive disorders of pregnancy than neonates of normotensive mothers. Body composition is different in term neonates of mothers with hypertensive disorders of pregnancy.

Society for Maternal-Fetal Medicine Special Statement: Quality metric for timely postpartum follow-up after severe hypertension.

Hypertensive disorders of pregnancy are a leading cause of maternal morbidity and mortality. Because postpartum exacerbation of severe hypertension is common, the American College of Obstetricians and Gynecologists recommends that patients with severe hypertension during the childbirth hospitalization be seen within 72 hours after discharge. In this statement, the Society for Maternal-Fetal Medicine proposes a uniform metric reflecting the rate of timely postpartum follow-up of patients with severe hypertension. The metric is designed to be measured using automated calculations based on billing codes derived from claims data. The metric can be used in quality improvement projects to increase the rate of timely follow-up in patients with severe hypertension during the childbirth hospitalization. Suggested steps for implementing such a project are outlined.

Society for Maternal-Fetal Medicine Special Statement: Best-practice recommendations for ultrasound network connectivity.

Prenatal ultrasound is an indispensable tool used by obstetrical care providers to assist in the everyday care of their pregnant patients. Alongside advancements in imaging, the electronic systems that support this technology have become more advanced. However, it is currently difficult for these individual systems to communicate with each other "out of the box." There is also minimal standardization of the type and format of data transmitted within these systems. Clinicians and system vendors must work collaboratively to create clinical and technical standards to serve as the foundation for increased interoperability among the various systems within each institutional network. Therefore, the Society for Maternal-Fetal Medicine Clinical Informatics Committee established an Ultrasound Electronic Health Record Subcommittee to facilitate collaboration between clinicians, including maternal-fetal medicine subspecialists, and ultrasound network component vendors. Based on the work of this subcommittee, the purpose of this document is to provide: (1) a basic understanding of ultrasound network architecture and capabilities, and (2) best-practice recommendations for electronic health record order design, obstetrical clinical data standards, and billing and coding practices.

Comparing Two Testing Strategies: Universal versus Symptomatic SARS-CoV-2 Testing in Obstetric Patients.

OBJECTIVE: To compare universal severe acute respiratory syndrome coronvirus-2 (SARS-CoV-2) testing to symptomatic testing at two large academic centers. STUDY DESIGN: We performed a retrospective cohort study comparing the approach to testing at two academic centers in Northeast Ohio. The study period started with the inception of symptomatic testing for SARS-CoV-2 at both institutions in March 2020. Women younger than 18 years were excluded. The primary outcome was the SARS-CoV-2 positivity rate in symptomatic pregnant patients at both institutions. Our coprimary outcome was the additional positivity rate obtained from universal testing at the University Hospitals. The secondary outcome of interest was the percentage of SARS-CoV-2 screen positive mothers with screen positive neonates. Data were analyzed using Mann-Whitney U test for continuous variables with chi-square and Fisher's exact tests for proportions. RESULTS: During the study period, 144 pregnant women with symptoms of coronavirus disease 2019 (COVID-19) were tested at MetroHealth of which 27 resulted as positive for SARS-CoV-2 (18.7% positivity rate). University Hospitals tested 392 pregnant women with symptoms of COVID-19 of which 67 resulted as positive for SARS-CoV-2 (positivity rate 17.0%). In the universal testing program at University Hospitals, an additional 2,870 tests were performed on asymptomatic pregnant women of which 30 were positive for SARS-CoV-2 (1.0% positivity rate).There were no SARS-CoV-2 positive infants in our cohort, and all cases of maternal critical illness occurred in symptomatic patients. CONCLUSION: Universal and symptomatic testing approaches demonstrated similar clinical performance within a single geographic region in obstetric patients. KEY POINTS: · There is a lack of data to recommend an optimal approach to SARS-CoV-2 testing in obstetric patients.. · Universal testing detected few additional cases of SARS-CoV-2.. · Maternal and neonatal outcomes were unaffected by testing strategy..

Society for Maternal-Fetal Medicine Special Statement: A maternal transport briefing form and checklist.

When performing a maternal transport between two facilities, numerous pieces of information must be communicated between physicians, nurses, and transport personnel, including the health status of 2 patients (mother and fetus), availability of bed space and personnel in 2 units at the receiving facility (labor and delivery unit and neonatal intensive care unit), arrangements for transportation, and inpatient and outpatient records. The amount and complexity of information creates a risk of medical error due to communication lapses. A cognitive aid such as a standardized form can help the team prepare for a transfer and provide a consistent framework for a handoff briefing among healthcare professionals. SMFM presents a sample briefing form to ensure that key elements are communicated for every maternal transport. Practical suggestions are given to help facilities customize the form and implement it on their units.

Society for Maternal-Fetal Medicine Special Statement: Updated checklists for pregnancy management in persons with HIV.

Optimal management of HIV-positive pregnant individuals involves many specific interventions made by many healthcare professionals at specific time-points before, during, and after pregnancy. Errors of omission are likely unless those professionals use a cognitive aid such as a checklist as a reminder of critical steps. In this document, SMFM presents updated and expanded checklists to help ensure that all relevant elements are considered for every person with HIV during prepregnancy, antepartum, intrapartum, and postpartum periods. The checklists are intended to be used as tools to facilitate the care of individuals with HIV during all phases of pregnancy care. Their use should improve the safety of HIV-positive patients by ensuring that appropriate treatment is given and relevant information is shared with consultative services. Routine use should also facilitate improved documentation, communication, and continuity of care before, during, and after pregnancy.

SMFM Special Statement: Who's who in patient safety and quality for maternal healthcare in the United States.

There are many organizations in the United States concerned with the improvement of patient safety and healthcare quality. In this overview, we provide a synopsis of the major entities whose work is relevant to maternal healthcare. For each organization, we summarize its mission, vision, major programs, and relationships with other entities. We include 13 entities with broad scope covering all types of healthcare; 9 organizations whose focus is maternal-child health; 6 women's health professional organizations with committees on patient safety, quality, or both; 12 organizations that offer accreditation, certification, or special distinction based on quality; and 5 organizations that rate, rank, or report quality metrics.

A risk of waiting: the weekly incidence of hypertensive disorders and associated maternal and neonatal morbidity in low-risk term pregnancies.

BACKGROUND: Elective induction of labor (eIOL) prior to 39 weeks' gestation is discouraged because of presumed fetal benefits. However, few data exist on the maternal risks of expectant management. To date, no study has evaluated the maternal risk of developing a hypertensive disorder of pregnancy with expectant management of a low-risk gravid at term. OBJECTIVE: We sought to evaluate the development of hypertensive disorders in term low-risk expectantly managed patients. STUDY DESIGN: This is a retrospective cross-sectional study from 19 US hospitals, from 2002 to 2008 (Safe Labor Consortium) including all nonanomalous, cephalic, singleton pregnancies at 37-41 weeks. Women with a history of hypertension, diabetes mellitus, cardiovascular disease, or planned cesarean delivery or from centers with incomplete hypertensive data were excluded. Women with eIOL in each week were compared with women managed expectantly until the next week of gestation or beyond. The primary outcome was the frequency of hypertensive complications. RESULTS: Of 114,651 low-risk deliveries, 12,772 (11.1%) had eIOL. The cohort was 49.2% nulliparous, 51.1% white, and obese (mean body mass index 30.2 kg/m(2)). The risk of developing any hypertension in expectantly managed women was 4.1% after 37 weeks, 3.5% after 38 weeks, 3.2% after 39 weeks, and 2.6% after 40 weeks. Compared with eIOL, women with hypertensive disorders had significantly higher rates of cesarean delivery and maternal morbidities (intensive care unit admission or death, third- or fourth-degree lacerations, maternal infections, and bleeding complications) at each week of gestation and the composite neonatal morbidity at 38 and 39 weeks of gestation. CONCLUSION: For women at low risk expectantly managed at term, there is a risk of developing hypertensive complications for each additional week of pregnancy, with associated increases in maternal and neonatal morbidities.

Intravenous drug use is associated with alloimmunization in pregnancy.

BACKGROUND: Anecdotal evidence has suggested an association of intravenous drug abuse with alloimmunization; however, published data are limited to case reports. OBJECTIVE: The purpose of this study was to determine whether women with a history of intravenous drug abuse have an increased risk of alloimmunization. STUDY DESIGN: A retrospective cohort study was performed with the use of data from a single-center blood bank and perinatal database from 2008-2014. Blood bank data were used to identify women with alloimmunization, which was defined as a positive antibody screen in pregnancy not due to naturally occurring antibodies, agglutinins, autoantibodies, or Rh immunoglobulin administration. Intravenous drug abuse was ascertained from a comprehensive database that has captured all drug abuse in pregnancy since 2008. For women who contributed >1 pregnancy to the database, only the most recent pregnancy was included. The rates of alloimmunization among women with a history of intravenous drug abuse and general obstetric populations were calculated and compared. The distribution of alloantibody types, proportion of Rh-group alloantibodies, and patient Rh status were assessed for intravenous and non-intravenous drug abuse-associated alloimmunization. Characteristics and outcomes between intravenous and non-intravenous drug abuse-associated alloimmunization were assessed for women with clinically significant alloantibodies. RESULTS: Alloimmunization was more common in women with a history of intravenous drug abuse (11/305 women; 3.6%) compared to women without a history of intravenous drug abuse (288/16,022 women; 1.8%; relative risk, 2.00; 95% confidence interval, 1.11-3.62). Needle-sharing was present in 7 and suspected in 4 women with an intravenous drug abuse history. Among women with a history of intravenous drug abuse, none had a history of transfusion or traditional risk factor for alloimmunization. The distribution of alloantibodies was different between intravenous drug abuse- and non-intravenous drug abuse-associated alloimmunization. Rh group alloantibodies and Rh-negative status were more common in women with a history of intravenous drug abuse. Among Rh-negative women with a history of intravenous drug abuse, 50% of RhD alloimmunization cases occurred in nulliparous women. The rate of multiple alloantibodies was not different between intravenous drug abuse- and non-intravenous drug abuse-associated alloimmunization. CONCLUSION: Maternal history of intravenous drug abuse is associated with an increased risk of alloimmunization. Approximately 1 in 30 intravenous drug abuse women may be diagnosed with an alloantibody in pregnancy. Given the current US opioid epidemic, increased vigilance in screening is required. Needle-sharing represents a possible mechanism for intravenous drug abuse-associated alloimmunization; however, limited obstetric care, failure to obtain Rh immunoglobulin, or failure to identify early pregnancy loss cannot be excluded.

Comparison of 2- and 3-Dimensional Sonography for Estimation of Birth Weight and Neonatal Adiposity in the Setting of Suspected Fetal Macrosomia.

OBJECTIVES: To compare the accuracy of 2-dimensional (2D) and 3-dimensional (3D) fetal measurements for prediction of birth weight Z score and neonatal adiposity (percent body fat) in the setting of suspected fetal macrosomia. METHODS: We conducted a prospective observational study of term singleton pregnancies with suspected macrosomia. Patients were enrolled on admission to labor and delivery and underwent sonographic examinations. Within 48 hours of delivery, neonatal anthropometric measurements were obtained. RESULTS: Thirty-four neonates were included in the analysis. Mothers were very obese (mean body mass index ± SD, 39.1 ± 7.8 kg/m(2)); 56.5% were white; and 39.1% had diabetes. Neonates were 38% female and had a mean birth weight of 3940.0 ± 496.8 g, percent body fat of 18.5% ± 4.0%, and Ponderal index of 2.8 ± 0.3 g/cm(3). Mean 2D estimated fetal weight was 3973 ± 443 g; mean 3D estimated fetal weight was 3803 ± 528 g; and mean thigh volume was 102.5 ± 19.6 cm(3). Both 2D and 3D measurements accounted for about half the variance in predicted birth weight (R(2) for 2D = 0.53, 71% within 10% of birth weight; R(2) for 3D = 0.47, 65% within 10% of birth weight). Thigh volume Z score was the prenatal parameter most highly correlated with both birth weight Z score (R(2) = 0.52; r = 0.72; 95% confidence interval, 0.54-0.84; P < .001) and percent body fat (R(2) = 0.22; r = 0.47; 95% confidence interval, 0.17-0.69; P = .04). CONCLUSIONS: In our population of fetuses with suspected macrosomia, fractional thigh volume was the best sonographic estimate of neonatal percent body fat and birth weight Z score. Future research on prediction of neonatal weight and adiposity in macrosomic fetuses should include an estimate of fetal soft tissue given the generalized increase in body fat of these fetuses.

A retrospective cohort study of factors relating to the longitudinal change in birth weight.

BACKGROUND: Recent reports have shown a decrease in birth weight, a change from prior steady increases. Therefore we sought to describe the demographic and anthropometric changes in singleton term fetal growth. METHODS: This was a retrospective cohort analysis of term singleton deliveries (37-42 weeks) from January 1, 1995 to January 1, 2010 at a single tertiary obstetric unit. We included all 43,217 neonates from term, singleton, non-anomalous pregnancies. Data were grouped into five 3-year intervals. Mean and median birth weight (BW), birth length (BL), and Ponderal Index (PI) were estimated by year, race and gestational age. Our primary outcome was change in BW over time. The secondary outcomes were changes in BL and PI over time. RESULTS: Mean and median BW decreased by 72 and 70 g respectively (p < 0.0001) over the 15 year period while BL also significantly decreased by 1.0 cm (P < 0.001). This contributed to an increase in the neonatal PI by 0.11 kg/m(3) (P < 0.001). Mean gestational age at delivery decreased while maternal BMI at delivery, hypertension, diabetes, and African American race increased. Adjusting for gestational age, race, infant sex, maternal BMI, smoking, diabetes, hypertension, and parity, year of birth contributed 0.1 % to the variance (-1.7 g/year; 26 g) of BW, 1.8% (-0.06 cm/year; 0.9 cm) of BL, and 0.7% (+0.008 kg/m(3)/year; 0.12 kg/m(3)) of PI. These findings were independent of the proportional change in race or gestational age. CONCLUSIONS: We observed a crude decrease in mean BW of 72 g and BL of 1 cm over 15 years. Furthermore, once controlling for gestational age, race, infant sex, maternal BMI, smoking, diabetes, hypertension, and parity, we identified that increasing year of birth was associated with a decrease in BW of 1.7 g/year. The significant increase in PI, despite the decrease in BW emphasizes the limitation of using birth weight alone to define changes in fetal growth.

Maternal and neonatal outcomes in electively induced low-risk term pregnancies.

OBJECTIVE: Elective induction of labor has been discouraged over concerns regarding increased complications. We evaluated the mode of delivery and maternal and neonatal morbidities in low-risk patients whose labor was electively induced or expectantly managed at term. STUDY DESIGN: This was a retrospective cross-sectional study from 12 US institutions (19 hospitals), 2002 through 2008 (Safe Labor Consortium). Healthy women with viable, vertex singleton pregnancies at 37-41 weeks of gestation were included. Women electively induced in each week were compared with women managed expectantly. The primary outcome was mode of delivery. RESULTS: Of 131,243 low-risk deliveries, 13,242 (10.1%) were electively induced. The risk of cesarean delivery was lower at each week of gestation with elective induction vs expectant management regardless of parity and modified Bishop score (for unfavorable nulliparous patients at: 37 weeks = 18.6% vs 34.2%, adjusted odds ratio, 0.40; [95% confidence interval, 0.18-0.88]; 38 weeks = 28.4% vs 35.4%, 0.65 [0.49-0.85]; 39 weeks = 23.6% vs 38.5%, 0.47 [0.38-0.57]; 40 weeks = 32.3% vs 42.3%, 0.70 [0.59-0.81]). Maternal infections were significantly lower with elective inductions. Major, minor, and respiratory neonatal morbidity composites were lower with elective inductions at ≥38 weeks (for nulliparous patients at: 38 weeks = adjusted odds ratio, 0.43; [95% confidence interval, 0.26-0.72]; 39 weeks = 0.75 [0.61-0.92]; 40 weeks = 0.65 [0.54-0.80]). CONCLUSION: Elective induction of labor at term is associated with decreased risks of cesarean delivery and other maternal and neonatal morbidities compared with expectant management regardless of parity or cervical status on admission.

Postpartum blood pressure control and the rate of readmission.

BACKGROUND: Postpartum hypertension is a major contributor to the rising maternal mortality rates in the United States, with nearly half of maternal deaths occurring after delivery. Previous studies have found evidence that the maximum blood pressure reading during labor and delivery admission can predict readmission; however, the optimal blood pressure to reduce the need for readmissions and additional medical treatment in the postpartum period is not known. OBJECTIVE: This study aimed to investigate the relationship between postpartum blood pressure control at discharge and readmission within the first 6 weeks after delivery. STUDY DESIGN: Data were obtained from Cosmos, an electronic health record-based, Health Insurance Portability and Accountability Act-defined limited dataset that includes more than 1.4 million birth encounters. All birthing parents with blood pressure data after delivery were included. Demographic information, medications, and readmissions were queried from the dataset. Patients were grouped into categories based on blood pressure readings in the 24 hours before discharge (≥160/110, ≥150/100, ≥140/90, ≥130/80, ≥120/80, and <120/80 mm Hg). The readmission rates across these groups were compared. Planned subanalyses included stratification by the use of antihypertensive medications and a sensitivity analysis using the highest blood pressure during admission. Covariates included maternal age, preexisting diabetes mellitus or lupus erythematosus, and body mass index. RESULTS: The analysis included 1,265,766 total birth encounters, 391,781 (30.9%) in the referent group (120/80 mm Hg), 392,592 (31.0%) in the group with <120/80 mm Hg, 249,414 (19.7%) in the group with ≥130/80 mm Hg, 16,125 (1.3%) in the group with ≥140/90 mm Hg, 50,659 (4.0%) in the group with ≥150/100 mm Hg, and 20,196 (1.6%) in the group with ≥160/110 mm Hg. In the first 6 weeks after delivery, readmission rates increased with higher blood pressure readings. More than 5% of postpartum patients with the highest blood pressure readings (≥160/110 mm Hg) were readmitted. These patients were almost 3 times more likely to be readmitted than patients whose highest blood pressure reading fell into the referent group (120/80 mm Hg) (odds ratio [OR], 2.90; 95% confidence interval, 2.69-3.12). Patients with blood pressures of >150/100 mm Hg (odds ratio, 2.72; 95% confidence interval, 2.58-2.87), >140/90 mm Hg (odds ratio, 2.03; 95% confidence interval, 1.95-2.11), and >130/80 mm Hg (odds ratio, 1.43; 95% confidence interval, 1.37-1.49) all had higher odds of readmission, whereas patients with a blood pressure of <120/80 mm Hg had a lower odds of readmission (odds ratio, 0.78; 95% confidence interval, 0.75-0.81). Patients who had higher blood pressures during admission but had improved control in the 24 hours before discharge had lower rates of readmission than those whose blood pressures remained elevated. In all blood pressure categories, patients who received an antihypertensive prescription had higher rates of readmission. CONCLUSION: In this large, national dataset, blood pressure control at discharge and readmission in the postpartum period were significantly correlated. Our data should inform postpartum hypertension treatment goals and the role of remote monitoring programs in improving maternal safety.

Pregnancy Outcomes of Nifedipine Compared With Labetalol for Oral Treatment of Mild Chronic Hypertension.

OBJECTIVE: To evaluate maternal and neonatal outcomes by type of antihypertensive used in participants of the CHAP (Chronic Hypertension in Pregnancy) trial. METHODS: We conducted a planned secondary analysis of CHAP, an open-label, multicenter, randomized trial of antihypertensive treatment compared with standard care (no treatment unless severe hypertension developed) in pregnant patients with mild chronic hypertension (blood pressure 140-159/90-104 mm Hg before 20 weeks of gestation) and singleton pregnancies. We performed three comparisons based on medications prescribed at enrollment: labetalol compared with standard care, nifedipine compared with standard care, and labetalol compared with nifedipine. Although active compared with standard care groups were randomized, medication assignment within the active treatment group was not random but based on clinician or patient preference. The primary outcome was the occurrence of superimposed preeclampsia with severe features, preterm birth before 35 weeks of gestation, placental abruption, or fetal or neonatal death. The key secondary outcome was small for gestational age (SGA) neonates. We also compared medication adverse effects between groups. Relative risks (RRs) and 95% CIs were estimated with log binomial regression to adjust for confounding. RESULTS: Of 2,292 participants analyzed, 720 (31.4%) received labetalol, 417 (18.2%) received nifedipine, and 1,155 (50.4%) received no treatment. The mean gestational age at enrollment was 10.5±3.7 weeks; nearly half of participants (47.5%) identified as non-Hispanic Black; and 44.5% used aspirin. The primary outcome occurred in 217 (30.1%), 130 (31.2%), and 427 (37.0%) in the labetalol, nifedipine, and standard care groups, respectively. Risk of the primary outcome was lower among those receiving treatment (labetalol use vs standard adjusted RR 0.82, 95% CI, 0.72-0.94; nifedipine use vs standard adjusted RR 0.84, 95% CI, 0.71-0.99), but there was no significant difference in risk when labetalol was compared with nifedipine (adjusted RR 0.98, 95% CI, 0.82-1.18). There were no significant differences in SGA or serious adverse events between participants receiving labetalol and those receiving nifedipine. CONCLUSION: No significant differences in predetermined maternal or neonatal outcomes were detected on the basis of the use of labetalol or nifedipine for treatment of chronic hypertension in pregnancy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02299414.

Mean Arterial Pressure and Neonatal Outcomes in Pregnancies Complicated by Mild Chronic Hypertension.

OBJECTIVE: To estimate the association between mean arterial pressure during pregnancy and neonatal outcomes in participants with chronic hypertension using data from the CHAP (Chronic Hypertension and Pregnancy) trial. METHODS: A secondary analysis of the CHAP trial, an open-label, multicenter randomized trial of antihypertensive treatment in pregnancy, was conducted. The CHAP trial enrolled participants with mild chronic hypertension (blood pressure [BP] 140-159/90-104 mm Hg) and singleton pregnancies less than 23 weeks of gestation, randomizing them to active treatment (maintained on antihypertensive therapy with a goal BP below 140/90 mm Hg) or standard treatment (control; antihypertensives withheld unless BP reached 160 mm Hg systolic BP or higher or 105 mm Hg diastolic BP or higher). We used logistic regression to measure the strength of association between mean arterial pressure (average and highest across study visits) and to select neonatal outcomes. Unadjusted and adjusted odds ratios (per 1-unit increase in millimeters of mercury) of the primary neonatal composite outcome (bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, or intraventricular hemorrhage grade 3 or 4) and individual secondary outcomes (neonatal intensive care unit admission [NICU], low birth weight [LBW] below 2,500 g, and small for gestational age [SGA]) were calculated. RESULTS: A total of 2,284 participants were included: 1,155 active and 1,129 control. Adjusted models controlling for randomization group demonstrated that increasing average mean arterial pressure per millimeter of mercury was associated with an increase in each neonatal outcome examined except NEC, specifically neonatal composite (adjusted odds ratio [aOR] 1.12, 95% CI, 1.09-1.16), NICU admission (aOR 1.07, 95% CI, 1.06-1.08), LBW (aOR 1.12, 95% CI, 1.11-1.14), SGA below the fifth percentile (aOR 1.03, 95% CI, 1.01-1.06), and SGA below the 10th percentile (aOR 1.02, 95% CI, 1.01-1.04). Models using the highest mean arterial pressure as opposed to average mean arterial pressure also demonstrated consistent associations. CONCLUSION: Increasing mean arterial pressure was positively associated with most adverse neonatal outcomes except NEC. Given that the relationship between mean arterial pressure and adverse pregnancy outcomes may not be consistent at all mean arterial pressure levels, future work should attempt to further elucidate whether there is an absolute threshold or relative change in mean arterial pressure at which fetal benefits are optimized along with maternal benefits. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT02299414.